Practicalities for BWC Implementation in Practicalities for BWC Implementation in Georgia and Confidence Building Georgia and Confidence Building

Measures ReportingMeasures Reporting

Lela Bakanidze, PhDLela Bakanidze, PhD

REGIONAL WORKSHOP REGIONAL WORKSHOP ON NATIONAL IMPLEMENTATIONON NATIONAL IMPLEMENTATION

Chisinau, Republic of Moldova Chisinau, Republic of Moldova 2222--24 June 201124 June 2011

22

The National Center for Disease Control and Public Health (NCDThe National Center for Disease Control and Public Health (NCDC) was C) was built on the foundation of the Georgian Station for Plague Contrbuilt on the foundation of the Georgian Station for Plague Control in 1996. ol in 1996. It employs 200 personnel It employs 200 personnel

-- 60% are specialists with a university education 60% are specialists with a university education -- 35 of them have advanced scientific degrees35 of them have advanced scientific degrees

NNCDC Main Responsibilities Include:CDC Main Responsibilities Include:

Surveillance on communicable and nonSurveillance on communicable and non--communicable communicable diseases, including outbreak investigations, IHR focal point diseases, including outbreak investigations, IHR focal point Control and prevention of public health diseases Control and prevention of public health diseases Immunization programs Immunization programs Organizing National Referral LaboratoriesOrganizing National Referral LaboratoriesHealth promotion Health promotion Medical statisticsMedical statisticsNational collection of pathogens is located at NCDCNational collection of pathogens is located at NCDCTraining and continuing educationTraining and continuing educationEnsuring biosecurity and biosafetyEnsuring biosecurity and biosafety

NCDC owns national collection of live microorganisms, and , amonNCDC owns national collection of live microorganisms, and , among them are EDPs like g them are EDPs like Y. pestis, F. Y. pestis, F. tularensis, B. anthracis,tularensis, B. anthracis, etc.etc.

NCDC partners with:NCDC partners with:

WHO, UNICEF, UNFPA, WB, US (HHS, DOD, DOE, USAID), ISTC, STCU, WHO, UNICEF, UNFPA, WB, US (HHS, DOD, DOE, USAID), ISTC, STCU, SIDA, Global Fund, GAVI, VRF, JAICA, etc.SIDA, Global Fund, GAVI, VRF, JAICA, etc.

National Center for Disease Control (NCDC)

The past

As a former Soviet Union (FSU) republic, Georgia As a former Soviet Union (FSU) republic, Georgia shared in the past the same legislation (including shared in the past the same legislation (including biosafety regulations pertaining to especially biosafety regulations pertaining to especially dangerous pathogens) with the other republics of dangerous pathogens) with the other republics of the FSUthe FSU

During Soviet time, the work During Soviet time, the work with EDPs was regulated by:with EDPs was regulated by:

The Decree of the Ministry Of Health of The Decree of the Ministry Of Health of USSR USSR ““Concerning Rules of Registration, Concerning Rules of Registration, Containment, Handling and Transfer of Containment, Handling and Transfer of Cultures of Pathogenic Bacteria, Viruses, Cultures of Pathogenic Bacteria, Viruses, Rikketsia, Fungi, Protozoa and others, also Rikketsia, Fungi, Protozoa and others, also Bacterial Toxins and Poisons of Biological Bacterial Toxins and Poisons of Biological OriginOrigin" approved by the Ministry of Health " approved by the Ministry of Health of USSR, 18.05.79of USSR, 18.05.79..““Instruction on Regime of Control of Instruction on Regime of Control of Epidemics while Working with Materials Epidemics while Working with Materials Infected or Suspected to be Infected with Infected or Suspected to be Infected with Causative Agents of Infectious Diseases of Causative Agents of Infectious Diseases of II--II GroupsII Groups”” approved by the Ministry of approved by the Ministry of Health of USSR Health of USSR 29.06.197829.06.1978

NCDC Statute was approved by the President of Georgia by PresideNCDC Statute was approved by the President of Georgia by Presidential Decree # 55 ntial Decree # 55 (21.02.2003). (21.02.2003).

The Statute, among the functions and activities of NCDC, lists:The Statute, among the functions and activities of NCDC, lists:•• ““detection of agents causing epidemics and outbreaksdetection of agents causing epidemics and outbreaks””, , ““carrying out surveillancecarrying out surveillance””,,•• ““establishing national collection of bacteria and virusesestablishing national collection of bacteria and viruses””, , •• ””participation in preparing normative and methodological documentparticipation in preparing normative and methodological documentation under its competenciesation under its competencies”” , ,

etc. etc.

In todayIn today’’s world, there is an increased risk of misuse of especially dangs world, there is an increased risk of misuse of especially dangerous pathogens erous pathogens (EDPs) as (EDPs) as ““weaponsweapons””, for the purpose of causing harm, for the purpose of causing harm

Therefore, it is very important to prevent EDPs from falling intTherefore, it is very important to prevent EDPs from falling into the wrong hands and a need o the wrong hands and a need to keep them secureto keep them secure

Biosecurity does not only refer to physical security measures buBiosecurity does not only refer to physical security measures but also to personnel reliability t also to personnel reliability measures.measures.

The Present

US DoD DTRA /Cooperative Threat Reduction Program’s Goals in Georgia

Support human, environmental, and Support human, environmental, and veterinary disease monitoring veterinary disease monitoring Ensure close cooperation among all Ensure close cooperation among all relevant ministries and institutes and relevant ministries and institutes and international organizationsinternational organizationsPromote potential for integration into a Promote potential for integration into a regional disease surveillance systemregional disease surveillance systemEnsure biosecurity and biosafety of Ensure biosecurity and biosafety of biological facilities.biological facilities.

Increased BiosecurityIncreased Biosecurity

Laboratories and repository were Laboratories and repository were renovated by DTRArenovated by DTRA

Before AfterBefore After

BWC implementation in Georgia

Each state party to the BWC is legally obligated to implement the Article 1 prohibitions in its national legal jurisdiction

Georgia has extensive legislative measures in place to ensure that all activities on its territory are treaty-compliant and that prohibited activities are deterred and detected and perpetrators punished

Legislative basisThe issues of export of conventional weapons and technologies related to them are regulated by the following laws:– The Law of Georgia on Weapons;– The Law of Georgia on Export and Import Control of Weapons, Military

Equipment and Dual-Use Materials;– The Law of Georgia on Basis of Issuing License and Permit for

Production Activities.In addition to the above-mentioned laws, there are other legal acts and mechanisms, which form the core of the state regulation system of non-proliferation of weapons, in particular:– Criminal Code of Georgia;– Decree # 408 of the President of Georgia, dated September 22, 2002, on

Certain Measures for Settlement of Issues on Export, Re-export and Transit of Dual-Use Materials Subject to Export Control;

– Decree # 424 of the President of Georgia, dated July 4, 1999, on Certain Measures for Export Control of Dual-Use Materials (Technologies, Equipment, Service).

Legislative basis (continued)The issues of WMDs and related technologies are regulated by the following provisions of the Criminal Code of Georgia (pertain to Article I of BWC):

In compliance with Article 406, the crime against the mankind consists in “production, purchase or sale of the chemical, biological or other weapons of mass destruction prohibited under the International Treaties that Georgia is party to”and shall carry legal consequences of imprisonment ranging from 8 to 15 years in length.

– Prohibits Infringement of safety rules for handling microbiological or other biological agents and toxins– Bans preparation, purchase, sale of BW – Bans transportation of BW– Bans export of WMD– Bans use of WMD

Law of Export Control (pertains to Article III of BWC):

– “Disease agents, their genetically altered forms, and fragments of genetical material which can be used for the creation of bacteriological (biological) and toxin weapons, control lists of which are established by international nonproliferation regimes’ subject to export control”

– Illicit export of technology, scientific-technical information or service for the production of weapons of mass destruction or military equipment, their transportation, whereon special export control is imposed shall be punishable by fine or imprisonment ranging from 3 to 5 years in length.

The Law of Georgia on Guarantees and Promotion of the Activities on Investments

According to Article 9 of this Law, it is prohibited to invest in:

a) development, production and proliferation of nuclear, bacteriological and chemical weapons;

b) creation of testing areas for nuclear, bacteriological, and chemical weapons;

c) import of nuclear and toxic remains with a view to their burial or disposal;

Law of Georgia Law of Georgia ““on Public on Public Health Health ””-- (27.06.2007)(27.06.2007)

Chapter V Chapter V -- ““Providing Biosecurity/ BiosafetyProviding Biosecurity/ Biosafety””, , Cl.16 Cl.16 -- Providing Biosecurity/ Biosafety;Providing Biosecurity/ Biosafety;Cl.17 Cl.17 -- Limitation of PLimitation of Posessionosession, Use, Transfer, , Use, Transfer, Transportation and Destruction of Causative Agents of Transportation and Destruction of Causative Agents of Especially dangerous Infections;Especially dangerous Infections;Cl.18 Cl.18 -- Destruction of Causative Agents of Especially Destruction of Causative Agents of Especially dangerous Infections;dangerous Infections;Cl.19 Cl.19 –– Import and export of Causative Agents of Import and export of Causative Agents of Especially dangerous Infections;Especially dangerous Infections;Cl.20 Cl.20 –– Functions of Sufficient Institutions working on Functions of Sufficient Institutions working on Biosafety/Biosecurity;Biosafety/Biosecurity;Cl.21 Cl.21 –– Establishing Unique Laboratory System for Establishing Unique Laboratory System for Detection, Surveillance and Response on Causative Agents Detection, Surveillance and Response on Causative Agents of Especially dangerous Infections.of Especially dangerous Infections.

Bilateral agreementsAgreement Between Georgia and the USA on Cooperation in the Sphere of Prevention of Proliferation of WMDs and on Expansion of Relations in the Defence and Military Sphere;

Agreement Between the State Department of State Border Defence of Georgia and the Department of Defence of the USA on Rendering Assistance in Establishment of System of Export Control For Prevention of Proliferation of WMDs in Georgia;

Agreement Between the Government of Georgia and the Government of the USA on Insuring the Programme of Prevention of Terrorism;

Agreement Between the Department of Defence of the United States of America and the Ministry of Defence of Georgia On Cooperation in the Sphere of Prevention of Spread of Technologies, Pathogens and Information Related to Development of Biological Weapons.

Biosafety/Biosecurity = CrossBiosafety/Biosecurity = Cross--Cutting, Essential Cutting, Essential Elements of Health Security and Biological NonElements of Health Security and Biological Non--ProliferationProliferation

WHO IHRs (2005)WHO IHRs (2005) BWCBWC UNSCR 1540UNSCR 1540

Applicability:Applicability: All 192 UN Member States 163 States Parties All 192 UN Member States

Purpose:Purpose:

“to prevent, protect, protect against, control and

provide a public health response to the

international spread of disease…”

To prohibit the development,production, acquisition, transfer, stockpiling and use of biological

and toxin weapons

To prohibit non-State actorsfrom developing, acquiring, manufacturing, possessing, transporting, transferring or using nuclear, chemical or

biological weapons and their delivery systems.

Requirements:Requirements:

8 core capacities “to detect, assess, notify, and report events” [Laboratory core

capacity includes biosafety / biosecurity]

Any necessary measures to prohibit and prevent the development, production, stockpiling, acquisition,

retention, transfer or use of biological weapons

Domestic controls to prevent the proliferation of nuclear, chemical

and biological weapons, their means of delivery, and related

materials

Entry into Entry into force:force:

15 June 2007 26 March 1975 28 April 2004

Mandated Mandated reporting / reporting /

where / when:where / when:

Status of implementation / WHO / “As soon as possible but no later than five years

from entry into force …"

None*“CBM voluntary reporting / BWC

ISU/ every year by 15 April

Status of implementation / 1540 Committee / “without delay”

Biosafety / BiosecurityBiosafety / Biosecurity

Georgia joined BTWC in 1995

Ministry of Foreign AffairsMinistry of Foreign AffairsDepartment of Disarmament Department of Disarmament

Policy and Euro Policy and Euro –– Atlantic Atlantic IntegrationIntegration

National Center for National Center for Disease Control and Disease Control and

Public HealthPublic Health

BWC ISU report on CBM submission by Form

Georgia

CBM A Part 1

CBM A Part 2

CBM B

CBM CCBM D

CBM ECBM F

CBM G

CBM Forms

CBM A – Part 1: Exchange of data on research centres and laboratories;

– Part 2: Exchange of information on national biological defence research and development programmes.

CBM B- Exchange of information on outbreaks of infectious diseases and similar occurrences caused by toxins.

CBM C -Encouragement of publication of results and promotion of use of knowledge

CBM D- Active promotion of contacts

CBM E- Declaration of legislation, regulations and other measures.

CBM F- Declaration of past activities in offensive and/or defensive biological research and development programmes.

CBM G- Declaration of vaccine production

CBM A Part 1 and Part 2There are no maximum containment laboratories in Georgia.

The highest biosafety level is BSL2+, and is NCDC (Tbilisi campus and branches in Kutaisi and Batumi), Laboratory of the Ministry of Agriculture (LMA) of Georgia with branches in Kutaisi and Akhaltsikhe.

The new Central Public Health Reference Laboratory is constructed.

Disease2004 2005 2006 2007 2008 2009 2010

Anthrax 3 (17) 19 38 3 (9)*33**

7 (20)*42**

4 (12)*26**

1 (3) *25 **

Tularemia - - 4 1 (26)*31**

5** 1* 3 **

Typhoid fever - - - - - 1* 0

Shigellosis 4 (388) 4 (107) 2 (32) 1 (5) 103** 96** 159**

Escherichia coli 1 (10) 1 (42) 1 (31) 2 (33) 1 (11)*736 **

626 ** 1 (20)*752 **

Hepatitis A 1 (7) 2 (35) 2 (189) 9 (132) 5 (28)**860**

6 (70)*328**

103 **

Trichinelosis 4 (97) 256** 27** 48** 18** 2* 1 (4)*

8 **

Botulism 9 (25) 19** 40** 17** 8(30)* 12** 2(4)* 8**

21 *

Brucellosis 1 (10) 129** 89** 169** 158** 162** 9 (28) *

171 **

Salmonellosis 3 (133) 6 (80) 4 (36) 4 (94) 160 ** 165 **

1(44)*

1 (7)*

70 **Possibly of Infectious Etiology

2 (25) 3 (260) 3 (381) 3(119)*10782 **

9904**2 (121)*

9 (135) *19626**

CBM B- Exchange of information on outbreaks of infectious diseases and similar occurrences caused by toxins

* - In brackets total number of cases for all outbreaks** - Sporadic cases

CBM C -Encouragement of publication of results and promotion of use of knowledge

•E. Zhgenti, G. Chanturia, R. Jashi, M. Kekelidze, R. Obiso, S. Francesconi, L.Bakanidze, N. Tsertsvadze. “Rapid Identification of Atypical Y. pestis Strains Isolated in Natural Foci of Georgia”,Abstract, Yersinia 10th International Symposium, Recife, Brazil, October 23 – 27, 2010. •16.N. Mebonia, N. Chakvetadze, M. Mirtskulava, - The abstract „Possible modification of risk factors for peptic ulcer among persons with Helicobacter pylori infection in Georgia”, European Scientific Conference on Applied Infectious Disease Epidemiology (ESCAIDE) , Lisbon, Portugal, November 11-13 2010, p.85•17. G. Babuadze, K. Sidamonidze, I. Kalandadze, M. Iosava, E. Giorgobiani, G. Chanturia. The abstract “New Leishmaniasis foci in Western Georgia ”, Abstract # 199, Abstract Book, American Society of Tropical Medicine and Hygiene 59th Annual Meetimg, November 3-7, 2010, Atlanta, Georgia,USA, p.60•18. P. Imnadze, S. Tsanava, N. Tsertsvadze, L. Bakanidze, R. Obiso, T. Onashvili, M. Nokolaishvili, M. Zakareishvili, I. Berdaze, M. Kokhreidze- The abstract “Surveillance on Zoonoses in Georgia: A Joint Effort of Public Health and Veterinary Services ”, Abstract # LB-2118, Abstract Book, American Society of Tropical Medicine and Hygiene 59th Annual Meetimg, November 3-7, 2010, Atlanta, Georgia,USA.•19. G. Babuadze, M. Iosava, L. Bakanidze. “The Anopheles Mosquitoes: their Role in Malaria Transmission in Georgia ”, in book “Pandemics and Bioterrorism”, The NATO Science for Peace and Security Program, 2010, pp. 221-226

CBM D- Active promotion of contactsJune 24 – 27, 2008, NCDC held NATO “Science for Peace”Programme – funded workshop “Advances in Surveillance, Detection, and Identification of Emerging and Endemic Pathogens”.

Workshop attended by more than 50 scientists from 10 countries –USA, Russia, France, Germany, Kazakhstan, Ukraine, Macedonia, UK, Azerbaijan and Georgia.

Active participation in biannual meetings of the BWC

– 2009: joint presentations with US and UK at the Meeting of Experts

– 2010: joint presentation with US about the international workshop on “Public Health, Security, and Law Public Health, Security, and Law Enforcement Partnership in BioEnforcement Partnership in Bio--Incident PreIncident Pre--Planning and ResponsePlanning and Response””and and Southern Caucasus Bioshield Southern Caucasus Bioshield 2010 2010 tabletop exercise organized in Tbilisi, Georgia

Effective national action for BTWC implementation in Georgia

- summary -

Legislation and regulationsBiosafety and BiosecurityOversight of scienceEducation and awarenessDisease surveillance

EU Statement during the 2009 BTWC Meeting of States Parties

• “The misuse of life sciences and biological agents and toxins could result in high consequence events that probably would constitute major challenges to the international community.

• We have to prevent biological agents from ever being developed and used as weapons.

• Maximum cooperation and assistance in areas concerning disease surveillance, detection, diagnoses, and containment of infectious disease would not only benefit global health, but also contribute to upholding the norms and commitments enshrined in the BTWC”.

ON BEHALF OF THE EUROPEAN UNION. THE CANDIDATE COUNTRIES TURKEY, CROATIA AND THE FORMER YUGOSLAV REPUBLIC OF MACEDONIA*, THE COUNTRIES OF THE STABILISATION AND ASSOCIATION PROCESS AND POTENTIAL CANDIDATES ALBANIA, BOSNIA AND HERZEGOVINA,

MONTENEGRO, SERBIA, AS WELL AS UKRAINE, THE REPUBLIC OF MOLDOVA, ARMENIA AND GEORGIA ALIGN THEMSELVES WITH THIS DECLARATION.

Thank You!Thank You!

Lela Lela BakanidzeBakanidze, Ph.D., Ph.D.President

Georgian Biosafety Association

Tbilisi, Georgiathreatred@ncdc.ge